Standard No.:	YY/T 1441-2016
English Name:	General requirements of performance evaluation of in vitro diagnostic medical devices
Chinese Name:	体外诊断医疗器械性能评估通用要求
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	China Food and Drug Adminstration
Issued on:	2016-01-26
Implemented on:	2017-1-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	130.00
Delivery:	via email in 1~3 business day

本标准规定了制造商在体外诊断医疗器械性能评估研究中对研究计划、实施、评估和制定文件的职责和总体要求。
本标准适用于对体外诊断医疗器械的性能评估。本标准不适用于对某一特定体外诊断医疗器械或某一具体用途的评估方案。